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Halfaker and Associates, LLC, Selected as a Prime Contractor Supporting the Food and Drug Administration

July 28, 2016

ARLINGTON, Va., July 28, 2016 – Halfaker and Associates, LLC (Halfaker), a technology solutions provider within the Federal Government’s health, intelligence, defense, and security sectors announced today that it was awarded the Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH) Submission Tracking and Report (CSTAR) contract, a Blanket Purchase Agreement (BPA) with a ceiling of $75 million. Under the BPA Halfaker will provide full life-cycle management support of the CSTAR system including, development, modernization, and enhancement work.

The CSTAR system is a web-based business process management solution designed for the FDA’s complex market clearance process for medical devices. CSTAR directly supports reviewers in the assessment, workload management, tracking and reporting of pre-market medical device submissions that aim to diagnose health conditions and determine health status. To provide real-time and quality information to end-users, CDRH has invested heavily in ensuring CSTAR continues to meet FDA's regulatory needs and also enable improved data exchange with industry by taking advantage of standards and newer technologies.

“We are eager to use innovative methodologies, such as our digital services capabilities, to improve and enhance the functionality of CSTAR and support CDRH adapt to the ever changing demands of the future while ensuring reliable operations are maintained” said Halfaker’s Business Development Director for Health and Human Services, Quintus Brown.

About Halfaker Halfaker and Associates (www.halfaker.com) creates innovative and practical technology solutions in the areas of Advanced Analytics, Software Engineering, IT Infrastructure and Cyber Security within health, intelligence, defense, and security sectors to help government organizations perform their critical missions. We are proud to be a service-disabled veteran-owned, woman-owned, 8(a), small business. To learn more about Halfaker, please visitwww.halfaker.com.